FDA 483 - Arizona Nutritional Supplements LLC - July 23, 2025

During an FDA inspection conducted from July 17-23, 2025, Arizona Nutritional Supplements LLC, a dietary supplement manufacturer located in Miami Lakes, FL, received a Form FDA 483 detailing significant observations. The primary issues identified relate to quality control and complaint handling, indicating a need to ensure adherence to good manufacturing practices for dietary supplements.

First, the inspection revealed the company's measures to prevent foreign material contamination were ineffective. Specifically, a metal detector on the packaging line failed to detect metal testing bars multiple times, indicating improper functioning. The metal detector's calibration sticker was outdated, and employees did not follow the standard operating procedure to notify management or maintenance when issues arose during testing. Verification logs also showed discrepancies regarding the availability and use of proper testing bars.

Second, the FDA observed that a qualified person at Arizona Nutritional Supplements LLC did not investigate a consumer complaint involving a possible allergic reaction to one of their dietary supplement products. The firm was initially unaware of this complaint, which had been reported to the FDA. While their client, responsible for final packaging, conducted an external review, the manufacturer failed to perform its own internal investigation into the adverse event.

These observations require the company to promptly review and enhance its quality control systems for foreign material exclusion and its procedures for thoroughly investigating product complaints to ensure full compliance with regulatory requirements.